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| Last Updated on PharmaCompass | Virtual Booth | Country | Holder | DMF No. | Subject | Submission Date | Status | Type | GDUFA DMF Review | GDUFA Review Date | GDUFA Payment Date |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 31/10/2025 | ZACH System SA |
France |
ZACH SYSTEM SA | 24929 | BOSENTAN MONOHYDRATE | 2011-05-09 | Active | II | Complete | 2014-08-25 | 2014-01-31 |
| 31/10/2025 | ChemWerth Inc |
U.S.A |
CHEMWERTH INC | 29001 | BOSENTAN, NON-STERILE BULK DRUG SUBSTANCE | 2015-03-03 | Active | II | Complete | 2015-09-09 | 2015-03-04 |
